Nimodipine Compounded Oral Suspension: A True Documented Medical Need

Author(s):  McElhiney Linda F

Issue:  Mar/Apr 2019 - Volume 23, Number 2
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Abstract:  What happens when there is an entire patient population, not just a specific patient, which cannot take a commercial product due to significant adverse effects, although the commercial product has a U.S. Food and Drug Administration-approved indication for the medical problem? What should or can be done in this situation? This article discusses this dilemma using a subarachnoid hemorrhage as an example of a true documented medical need, and discusses the option and circumstances surrounding the compounding of a nimodipine oral solution, a U.S. Food and Drug Administration–approved indication for the treatment of subarachnoid hemorrhages.

Related Keywords: nimodipine, dihydropyridine calcium channel blocker, formulations, US Food and Drug Administration, FDA, DQSA, subarachnoid hemorrhage, bleeding in brain, drug safety, dosage forms, adverse effects

Related Categories: FORMULATIONS, LEGAL, ADVERSE DRUG EVENTS, HEMOSTASIS, BLEEDING, ANTICOAGULATION, NEUROLOGY

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